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Introduction

Who will the course benefit?

Our Pharma Internal Auditor course is aimed at people who perform internal and external audits, people who manage audit programmes as well as individuals who host  auditors of their own organisation.

Course overview:

This Pharma Internal Auditor course is designed for those new to auditing.  The course covers how to plan, perform, report and follow-up audits professionally.  Delegates will learn about GMP and how to audit against GMP (as a standard) as well as the newer requirements of Q10 (Quality Management) and the ramifications of this document to GMP, including recent updates to EU GMP Chapters 1 and 2.

Course contents:

Day 1     Quality Management Systems and auditing

• Quality Management Systems and their evolution
• GMP – structure and legal status
• Types of audits and reasons for performing them
• GMP requirements for internal and supplier audits
• GMP and Pharmaceutical Quality Management development
• ICH Q9 and 10
• An overview of ISO 9001 and how many of its requirements are incorporated into ICH Q10
• Effective audit planning and preparation

Day 2     The audit process

• Review of documentation before the audit
• Good auditing techniques
• Checklist construction
• The opening meeting
• Audit role-play exercise
• The closing meeting
• Finding faults and identifying opportunities for improvement
• Non-conformity reporting and corrective actions
• Audit reports and post-audit activities

Useful links

Speakers

• Peter Lavis United Kingdom
• Dominic Parry United Kingdom

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Venue

Holiday Inn Reading

Holiday Inn Reading, Reading South, 500 Basingstoke Road, Reading , RG2 0SL, United Kingdom

Organised by

Contact information

Dominic Parry
Inspired Pharma Training
1210 Parkview, Arlington Business Park, Theale, Reading, Berkshire RG7 4TY
+44 1635 866699
Contact us by email

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